Regulatory Focus™ > News Articles > Regulatory Recon: GSK: No Risk to Patients From Legionnaires' Bacteria at NC Plant (13 August 2015)

Regulatory Recon: GSK: No Risk to Patients From Legionnaires' Bacteria at NC Plant (13 August 2015)

Posted 13 August 2015 | By Michael Mezher 

Regulatory Recon: GSK: No Risk to Patients From Legionnaires' Bacteria at NC Plant (13 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • FDA Prevails in Challenge Over Methylphenidate ANDA Rating Downgrade, But the Decision is Appealed; Meanwhile, the Agency Flip-Flops on Dexmethylphenidate Bioequivalence Requirements (FDA Law Blog)
  • GlaxoSmithKline Finds No Legionnaires’ Risk at North Carolina Plant (WSJ-$) (FiercePharmaManufacturing)
  • How Bioinformatics Could Find the Next Breakthrough Cancer Drug (Forbes)
  • Basilea's ceftobiprole dubbed qualified infectious disease product (SCRIP-$)
  • More on FDA's Warning Over Kim Kardashian's Promotion of Morning Sickness Drug (WSJ-$) (NYTimes) (NBC News)
  • Beefed-Up Submission Delays Opdivo's 1st-Line Melanoma Timeline (SCRIP-$) (Press)
  • Apply User Fees to Postmarket Data Collection In MDUFA IV, Pew Argues (Gray Sheet-$)
  • Study Questions Premarket, Postmarket PMA Device Evidence (Gray Sheet-$)
  • Adaptive Study Design: How Many Subjects Do I Need For My ClinicalTrial? (MedDeviceOnline)
  • Where Are The Warning Letters? (Gray Sheet-$)
  • In a first, FDA clears a material enabling 3-D printing of dentures (FierceMedicalDevices)
  • Massachusetts bill would create first-in-nation cap on drug prices (FierceHealthPayer)
  • GDUFA Stakeholder Deadline May Come After Negotiations Conclude (Pink Sheet-$)

In Focus: International

  • Pfizer to reimburse GPs for extra workload caused by Lyrica (Pharmaceutical Journal)
  • QMS, AE Reporting Deviations Flagged Most in EU Postmarketing Inspections (FDANews)
  • CCEA approves proposal for strengthening drug regulatory system (Economic Times)
  • TSDCA inspection finds 21 drugs not-of-standard quality to initiate actions against perpetrators (PharmaBiz)
  • Around 43,000 samples of drugs sent for testing under national drugs survey (PharmaBiz)
  • Opposition grows in Malaysia and New Zealand on TPP drug provisions (FiercePharmaAsia)
  • Familiar Drugs May Block Ebola Virus Infection (DD&D)

US: Pharmaceuticals and Biotechnology

  • FDA Prevails in Challenge Over Methylphenidate ANDA Rating Downgrade, But the Decision is Appealed; Meanwhile, the Agency Flip-Flops on Dexmethylphenidate Bioequivalence Requirements (FDA Law Blog)
  • GlaxoSmithKline Finds No Legionnaires’ Risk at North Carolina Plant (WSJ-$) (FiercePharmaManufacturing)
  • How Bioinformatics Could Find the Next Breakthrough Cancer Drug (Forbes)
  • Basilea's ceftobiprole dubbed qualified infectious disease product (SCRIP-$)
  • Teva's Huntington's Pursuit Lends Insight Into Other Diseases (SCRIP-$)
  • Stem Cell Agency Funded Therapy for Blinding Disease Treats First Patients (CIRM)
  • More on FDA's Warning Over Kim Kardashian's Promotion of Morning Sickness Drug (WSJ-$) (NYTimes) (NBC News)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Beefed-Up Submission Delays Opdivo's 1st-Line Melanoma Timeline (SCRIP-$) (Press)
  • ASLAN receives orphan drug designation for cancer drug (BioSpectrum)
  • Pivotal Phase II study of investigational medicine venetoclax met primary endpoint in a hard-to-treat type of chronic lymphocytic leukemia (Press) (FierceBiotech)
  • Myrbetriq Gains New Contraindication, Warning (MPR)
  • Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease (Press)
  • Venetoclax meets pivotal Phase II endpoint in CLL (BioCentury)
  • FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Five-Year First-Line and Seven-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase (Press)
  • ImmunoCellular Therapeutics Reaches Agreement with FDA on Special Protocol Assessment (SPA) for ICT-107 Phase 3 Registrational Trial in Glioblastoma (Press)
  • BioDelivery Sciences Announces FDA Approval of New Formulation of ONSOLIS® (fentanyl buccal soluble film) CII (Press)
  • AbbVie to file leukaemia drug this year on PhII data (PharmaTimes)

US: Pharmaceuticals and Biotechnology: General

  • How to get a true ‘bird’s-eye view’ in clinical trials (MedCityNews)
  • Large Employers Look to Tighten Control Of Costs For Expensive Drugs (KHN)

US: Medical Devices

  • Apply User Fees to Postmarket Data Collection In MDUFA IV, Pew Argues (Gray Sheet-$)
  • Study Questions Premarket, Postmarket PMA Device Evidence (Gray Sheet-$)
  • Adaptive Study Design: How Many Subjects Do I Need For My ClinicalTrial? (MedDeviceOnline)
  • Where Are The Warning Letters? (Gray Sheet-$)
  • In a first, FDA clears a material enabling 3-D printing of dentures (FierceMedicalDevices)
  • What's the Real Reason for FDA Device Delays? (MDDI)
  • CyMedica wins CE Mark for QB1 (MassDevice)
  • Elastic Material Sticks to Skin, Releases Drugs When Stretched (medGadget)
  • Uptake Medical wins expanded CE Mark for InterVapor (MassDevice)
  • Biotronik launches 2 new studies (MassDevice)
  • Reimbursement: A Medical Device Company's Worst Nightmare? (GxP Lifeline)
  • NOWDiagnostics Inc. Receives FDA Clearance for ADEXUSDx hCG Test (Press)

US: Assorted and Government

  • Hearing scheduled for Mass. drug pricing bill (BioCentury)
  • Massachusetts bill would create first-in-nation cap on drug prices (FierceHealthPayer)
  • GDUFA Stakeholder Deadline May Come After Negotiations Conclude (Pink Sheet-$)
  • Recent OIG Advisory Opinions Involving Benefits Provided to Patients Are of Special Interest to Drug and Device Manufacturers (FDA Law Blog)
  • Arkansas buys lethal injection drugs, aims to end execution hiatus (Reuters)
  • No Kickback Penalty for Free Drugs, Inspector General Says (Law360-$)

Upcoming Meetings and Events              

Europe

  • Pfizer to reimburse GPs for extra workload caused by Lyrica (Pharmaceutical Journal)
  • QMS, AE Reporting Deviations Flagged Most in EU Postmarketing Inspections (FDANews)

Canada

India

  • CCEA approves proposal for strengthening drug regulatory system (Economic Times)
  • TSDCA inspection finds 21 drugs not-of-standard quality to initiate actions against perpetrators (PharmaBiz)
  • Around 43,000 samples of drugs sent for testing under national drugs survey (PharmaBiz)

Japan

  • Japan accepts Pluristem's regenerative cells as safe (BioSpectrum)

Ebola Outbreak

  • Familiar Drugs May Block Ebola Virus Infection (DD&D)
  • The New Weapon in The Fight Against Ebola And Other Deadly Pathogens (Forbes)

Other International

  • Opposition grows in Malaysia and New Zealand on TPP drug provisions (FiercePharmaAsia)

General Health and Other Interesting Articles

  • Feds want Lance Armstrong’s medical records. Would HIPAA allow it? (MedCityNews)
  • Lyme disease is vastly under-reported, CDC says (CBS News)

Regulatory Reconnaissance #617 – 13 August 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe